Alvogen can sell in the US generic lenalidomide on a volume-limited basis after March 2022, and without volume limitations in early 2026, after settling patent litigation with Celgene relating to the originator’s Revlimid. Dr Reddy's has also settled in Canada.
Alvogen and its subsidiary Lotus Pharmaceuticals have settled patent litigation with Celgene concerning the originator’s Revlimid (lenalidomide). This allows for generic entry of the multiple myeloma treatment on a confidential date.
“As part of the settlement, the parties will file consent judgments with the US district court for the district of New Jersey that enjoin Alvogen from marketing generic lenalidomide before the expiration of the
Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.
